U.S. patent number 5,992,000 [Application Number 08/951,550] was granted by the patent office on 1999-11-30 for stent crimper.
This patent grant is currently assigned to SciMed Life Systems, Inc.. Invention is credited to Terry V. Brown, Charles L. Euteneuer, Nam H. Hoang, John W. Humphrey, Leo M. Klisch, Christopher R. Larson, Jonathan C. Sell, Vladimir B. Tsukernik, Lawrence W. Ulanowski.
United States Patent |
5,992,000 |
Humphrey , et al. |
November 30, 1999 |
**Please see images for:
( Certificate of Correction ) ** |
Stent crimper
Abstract
An apparatus for crimping a stent to a catheter as well as a
method for crimping a stent to a catheter are disclosed in several
embodiments. The apparatus in its various embodiments involves the
application of a uniform radially inward force to a compressible
tube in which the stent and catheter are situated.
Inventors: |
Humphrey; John W. (Eden
Prairie, MN), Brown; Terry V. (Fridley, MN), Euteneuer;
Charles L. (St. Michael, MN), Hoang; Nam H.
(Minneapolis, MN), Klisch; Leo M. (Maple Grove, MN),
Larson; Christopher R. (St. Paul, MN), Sell; Jonathan C.
(West St. Paul, MN), Tsukernik; Vladimir B. (West Roxbury,
MA), Ulanowski; Lawrence W. (Brooklyn Park, MN) |
Assignee: |
SciMed Life Systems, Inc.
(Maple Grove, MN)
|
Family
ID: |
25491813 |
Appl.
No.: |
08/951,550 |
Filed: |
October 16, 1997 |
Current U.S.
Class: |
29/516; 29/282;
29/283.5 |
Current CPC
Class: |
A61F
2/958 (20130101); A61F 2/9526 (20200501); Y10T
29/53996 (20150115); A61F 2/9522 (20200501); Y10T
29/49927 (20150115); Y10T 29/53987 (20150115) |
Current International
Class: |
A61F
2/06 (20060101); B21D 039/00 () |
Field of
Search: |
;29/282,423,516,517,234,235,283,283.5 ;606/1,108,198 ;623/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0 630 623 A2 |
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Dec 1994 |
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EP |
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0 701 800 |
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Mar 1996 |
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EP |
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295 06 654 |
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Jul 1995 |
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DE |
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195 32 288 A1 |
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Mar 1997 |
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DE |
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WO 96/03092 A1 |
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Feb 1996 |
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WO |
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WO 97/20593 |
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Sep 1997 |
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WO |
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WO 98/19633 |
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May 1998 |
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WO |
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Other References
Derwent Abstract Accession No. 93-135787/199317, abstract of DE
4235004, 1993..
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Primary Examiner: Hughes; S. Thomas
Assistant Examiner: Cozart; Jermie E.
Attorney, Agent or Firm: Vidas, Arrett & Steinkraus
Claims
What is claimed is as follows:
1. An apparatus for compressing a stent onto a catheter, the stent
having a first end and a second end and a diameter, the apparatus
comprising a
retaining means for maintaining the position of the stent on the
catheter;
a die for applying a uniform radial inward force to at least a
portion of the stent, the die having a bore, the bore having a
first end and a second end, the first end of the bore having a
diameter larger than the diameter of the stent, the second end of
the bore having a diameter smaller than the diameter of the stent;
and
a mounting apparatus comprising a rail upon which the die is
slidably mounted.
2. The apparatus of claim 1 wherein the mounting apparatus
comprises a catheter retaining means to prevent the catheter from
moving.
3. An apparatus for compressing a stent onto a catheter, the stent
having a first end and a second end and a diameter, the apparatus
comprising a
retaining means for maintaining the position of the stent on the
catheter;
a die for applying a uniform radial inward force to at least a
portion of the stent, the die having a bore, the bore having a
first end and a second end, the first end of the bore having a
diameter larger than the diameter of the stent, the second end of
the bore having a diameter smaller than the diameter of the stent;
and
a mounting apparatus comprising at least one rod upon which the die
is slidably mounted.
4. The apparatus of claim 3 wherein the die comprises a transparent
or translucent material.
5. The apparatus of claim 3 wherein the die has an interior
surface, the interior surface being lubricious.
6. The apparatus of claim 3 further comprising a stent and a
catheter.
7. The apparatus of claim 6 further comprising a balloon mounted
coaxially at least partially underneath the stent.
8. The apparatus of claim 3 wherein the die moves longitudinally
with respect to the stent.
9. A device for crimping a stent to a catheter, the stent having a
diameter prior to crimping, comprising:
a tubular plunger having a first end and a second end, the plunger
having an inner diameter exceeding the diameter of the stent prior
to crimping;
a deformable inner tube for receiving the stent and catheter from
the plunger, the inner tube fixedly attached to the second end of
the tubular plunger, the deformable inner tube having a first end
and a second end;
an outer tube, the outer tube having a first and a second end, the
outer tube notched at the second end so as to have a plurality of
oppositely situated wall sections at the second end, the second end
of the plunger slidably mounted in the first end of the outer tube
and the deformable inner tube residing within the outer tube;
a die slidably mounted on the outer tube, the die comprising an
outer housing and an inner housing, the outer housing in
communication with the inner housing, the inner housing having an
inner bore therethrough, the inner bore having a circular
cross-section at every point along the length of the inner bore,
the bore characterized by a minimum diameter, the diameter of the
stent prior to crimping exceeding the minimum diameter of the bore,
a portion of the inner tube traversing the bore, the die further
having one or more slots therethrough between the inner housing and
the outer housing, the slots arranged so as to receive the
plurality of oppositely situated wall sections in sliding
engagement; and
an end portion, the end portion residing at the second end of the
outer tube, the end portion optionally having a hole therein from
which the catheter may emanate; whereby the stent is crimped to the
catheter by inserting the stent and catheter through the plunger
and into the inner tube, and sliding the die along the outer tube
such that the die passes over the stent and applies a uniform
radial inward force to the stent.
10. The device of claim 9 wherein the inner tube is a braid.
11. The device of claim 10 further comprising a stent, the stent
residing in the flexible inner tube.
12. The device of claim 9 wherein the inner tube is made of a clear
or translucent material and the outer tube is made of a clear or
translucent material.
13. The device of claim 9 wherein the inner tube is attached to the
end portion.
14. The device of claim 9 wherein the end portion comprises a cap
mounted on the second end of the outer tube.
15. The device of claim 9 wherein the outer tube is closed at the
second end so as to form the end portion.
16. The device of claim 9 wherein the one or more portions of the
inner bore are tapered.
17. The device of claim 9 wherein the diameter of the inner tube is
stepped, the step serving as a stopper for the stent.
18. The device of claim 9 further comprising a mandril emanating
from the end portion and coaxial with the inner tube, at least a
portion of the mandril residing in the inner tube.
19. The device of claim 9 wherein the second end of the outer tube
comprises two oppositely situated wall sections and the die has two
slots therethrough to accommodate the wall sections.
20. The device of claim 9 wherein the second end of the outer tube
comprises three oppositely situated wall sections and the die has
three slots therethrough to accommodate the wall sections.
21. A method of crimping a stent onto a catheter, the catheter
having a balloon mounted thereon, by:
a) inserting the stent and catheter into the device of claim 9;
b) aligning the stent over the balloon by moving the stent, the
catheter or both;
c) slidably moving the die over the stent so as to apply an inward
radial force to at least a portion to the stent while preventing
the stent from sliding by applying tension to the inner tube by
pulling on the plunger; and
d) removing the catheter from the device.
Description
BACKGROUND OF THE INVENTION
This invention relates to an assembly and a method for fastening a
stent onto a catheter. This kind of device finds routine use in the
area of percutaneous transluminal coronary angioplasty (PTCA)
procedures, although it may be used in other types of procedures,
as well.
Stents and stent delivery assemblies are utilized in a number of
medical procedures and situations, and as such their structure and
function are well known. A stent is a generally cylindrical
prosthesis introduced via a catheter into a lumen of a body vessel
in a configuration having a generally reduced diameter and then
expanded to the diameter of the vessel. In its expanded
configuration, the stent supports and reinforces the vessel walls
while maintaining the vessel in an open, unobstructed
condition.
Inflation expandable stents are well known and widely available in
a variety of designs and configurations. Inflation expandable
stents are crimped to their reduced diameter about the delivery
catheter, then maneuvered to the deployment site and expanded to
the vessel diameter by fluid inflation of a balloon positioned
between the stent and the delivery catheter. The present invention
is particularly concerned with the crimping of inflation expandable
stents although self-expanding stent may be used as well.
An example is the stent described in PCT Application NO. 960 3092
A1, published Feb. 8, 1996, the content of which is incorporated
herein by reference.
In advancing an inflation expandable balloon through a body vessel
to the deployment site, the stent must be able to securely maintain
its axial position on the delivery catheter, without translocating
proximally or distally, and especially without becoming separated
from the catheter. Stents that are not properly secured or retained
to the catheter may slip and either be lost or be deployed in the
wrong location. The stent must be crimped in such a way as to
minimize or prevent altogether distortion of the stent and to
thereby prevent abrasion and/or reduce trauma of the vessel
walls.
In the past, this crimping has been done by hand resulting in
non-uniform crimps due to the application of uneven force to the
stent. A non-uniformly crimped stent must either be discarded or
re-crimped. Stents which have been crimped multiple times can
suffer from fatigue. Moreover, a non-uniform crimping can result in
scoring or other marking of the stent which can cause thrombosis. A
poorly crimped stent can also damage the underlying balloon. Other
methods of crimping stents include the use of mechanical devices
such as those disclosed in U.S. Pat. No. 5,546,646 to Williams et
al, U.S. Pat. No. 5,183,085 to Timmermans et al., U.S. Pat. No.
5,626,604 to Cottone, Jr. and WO 97/20593.
It is a goal of the present invention to produce a device,
optionally portable, to crimp a stent onto a catheter uniformly
while minimizing the distortion of and scoring and marking of the
stent and due to the crimping. This goal is accomplished in the
present invention in its many embodiments by applying a uniform
force to a compressible tube in which the stent and catheter are
situated.
In the description that follows it is understood that the invention
contemplates crimping a stent to a catheter with an expandable
region. Thus, when reference is made to crimping a stent to a
catheter, a balloon may be situated between the stent and the
catheter,or the stent may be crimped to a region of a catheter
having some other means for expanding.
SUMMARY OF THE INVENTION
The present invention provides an apparatus for compressing a stent
onto a catheter, the catheter preferably including are expandable
portions such as a balloon under the stent. The apparatus comprises
a retaining means for preventing the stent from sliding along the
catheter and a crimping means for applying a substantially uniform,
circumferential radial inward force to at least a portion of the
stent. The crimping means moves longitudinally with respect to the
stent and over it to apply a substantially uniform circumferential
radial inward crimping force to the stent.
In one embodiment, the retaining means comprises a peel away tube
mounted coaxially on the catheter adjacent to the proximal of the
stent. In another embodiment, the retaining means comprises
deformable tubing mounted coaxially on the catheter over the stent.
The deformable tubing has a first diameter prior to stretching and
a second smaller diameter after stretching. The deformable tubing
grips the uncrimped stent and holds it in place upon being
stretched.
In another embodiment, the crimping means comprises a tapered peel
away tube mounted coaxially on the catheter adjacent to the distal
end of the stent. The tapered peel away tube has a first diameter
larger than the diameter of the stent and a second diameter smaller
than the diameter of the uncrimped stent. The uniform
circumferential radial inward force is applied by sliding the
tapered peel away tube over the stent.
In another embodiment, the crimping means comprises a die having a
bore. The diameter of the bore is smaller than the diameter of the
stent. The uniform radial inward force is applied by introducing
the stent into the bore and sliding the die over the stent.
The present invention in another embodiment provides an apparatus
for compressing a stent comprising a tube having a first end and a
second end, the tube preferably having a longitudinal axis
coincident with the longitudinal axis of the apparatus, the tube
characterized by a first diameter in the absence of tension and a
second smaller diameter when longitudinal tension is provided on
the tube, the tube receiving a catheter and a stent to be crimped
to said catheter, said stent having an initial diameter prior to
being crimped and a final diameter after being crimped and a die
having a bore sized to crimp the stent, the longitudinal axis of
the bore coincident with the longitudinal axis of the tube, the
tube at least partially resting within the bore of the die. The
stent is crimped to the catheter with the above device by providing
tension to the tube thereby reducing its diameter and causing it to
grip the stent and sliding the die along the tube and over the
stent. The invention further comprises a slide means to which the
die is mounted to facilitate sliding the die over the stent.
In another embodiment of the invention, an apparatus for
compressing a stent is disclosed comprising a deformable tube and
tension applying means for applying longitudinal tension to the
deformable tube. The deformable tube, fastened to the tension
applying means is characterized by a first diameter in the absence
of tension and a second smaller diameter when longitudinal tension
is provided on the tube. A stent is crimped onto a catheter using
the above-described apparatus by applying longitudinal tension via
the tension applying means to the deformable tube whereby the
diameter of the deformable tube decreases as the tube is stretched,
thereby crimping the stent.
In another embodiment, the present invention is directed to a
method of crimping a stent onto a catheter. The method comprises
placing a stent coaxially on stent bearing region of the catheter,
placing a stent retaining means on the catheter, applying a stent
crimping means, the means being capable of applying a uniform
radial inward force to at least a portion of the stent, to the
stent and removing the stent crimping means and stent retaining
means. The stent retention means may comprises a peel away tube
mounted adjacent to the stent or may comprise a deformable tube,
the diameter of the tube reducing on stretching, which is placed
over the stent and stretched. The stent crimping means may comprise
a tapered tube slidably mounted coaxially over the catheter, the
tube having first and second ends, the first end having a larger
diameter than the stent and the second end having a smaller
diameter than the stent. In use, the stent crimping means is
applied by sliding it over the stent.
In yet another embodiment, the present invention is directed to a
method for affixing a stent onto a catheter. The method involves
placing a stent coaxially on the stent bearing region of the
catheter and optionally placing a peel away tube coaxially on the
stent bearing region of the catheter. The first end of a tapered,
optionally peel-away sheath having first and second ends, the first
end having a larger diameter than the second end, is placed
coaxially over a part of the peel away tube. The peel-away tube and
stent and catheter therein is slidably moved through the tapered
peel away sheath until the stent is crimped onto the catheter.
Thereafter, the peel-away sheath is peeled away, as is the optional
peel-away tube.
In yet another embodiment, the present invention is directed to an
apparatus for crimping a stent comprising a catheter, the catheter
having a stent bearing region and a stent mounted thereon and,
optionally, a balloon mounted at least partially underneath the
stent. The apparatus further comprises a peel away tube mounted
coaxially on the catheter adjacent to one end of the stent, the
peel away tube serving as a stop to prevent sliding of the stent
during crimping. The apparatus further comprises a tapered peel
away tube surrounding the catheter at the second end of the stent.
The diameter of the first end of the tapered peel away tube exceeds
the diameter of the uncrimped stent while the diameter of the
second end of the tapered peel away tube is less than the diameter
of the uncrimped stent.
In yet another embodiment, the present invention is directed to an
apparatus for crimping a stent comprising a tubular plunger having
a first end and a second end, the plunger having an inner diameter
exceeding the diameter of the stent prior to crimping, a deformable
inner tube for receiving the stent and catheter from the plunger,
the inner tube fixedly attached to the second end of the tubular
plunger, the deformable inner tube having a first end and a second
end, an outer tube, the outer tube having a first and a second end,
the outer tube notched at the second end so as to have a plurality
of oppositely situated wall sections at the second end, the second
end of the plunger slidably mounted in the first end of the outer
tube and the deformable inner tube residing within the outer tube,
a die slidably mounted on the outer tube, the die comprising an
outer housing and an inner housing, the outer housing in
communication with the inner housing, the inner housing having an
inner bore therethrough, the inner bore having a circular
cross-section at every point along the length of the inner bore,
the bore characterized by a minimum diameter, the diameter of the
stent prior to crimping exceeding the minimum diameter of the bore,
a portion of the inner tube traversing the bore, the die further
having one or more slots therethrough between the inner housing and
the outer housing, the slots arranged so as to receive the
plurality of oppositely situated wall sections in sliding
engagement and an end portion, the end portion residing at the
second end of the outer tube, the end portion optionally having a
hole therein from which the catheter may emanate. The stent is
crimped to the catheter by inserting the stent and catheter through
the plunger and into the inner tube, and sliding the die along the
outer tube such that the die passes over the stent and applies a
uniform radial inward force to the stent.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 shows a side view of one embodiment of the present
invention;
FIG. 2 shows a side view of a braid element used in the
invention;
FIG. 3 show a perspective view of a die moving over a stent or a
catheter;
FIG. 4 shows a perspective view of another embodiment of the
present invention including a mounting apparatus;
FIG. 5 shows a side view of another embodiment of the present
invention including a mounting apparatus;
FIG. 6 shows a side view of another embodiment of the present
invention;
FIG. 7 shows a side view of another embodiment of the present
invention;
FIG. 8 shows a side view of another embodiment of the present
invention;
FIG. 9 shows a side view of another embodiment of the present
invention;
FIG. 10a shows a side view of another embodiment of the present
invention;
FIGS. 10b and 10c show a side view of a stent in the process of
being crimped in the stent crimper depicted in FIG. 10a;
FIG. 11a is a side elevational view sectioned vertically along the
longitudinal axis of yet another embodiment of the invention;
FIG. 11b shows the stent crimper of FIG. 11a absent the catheter
and with an optional mandrel present.
FIG. 12 is a detailed fragmentary view of the outer tube depicted
in FIG. 11 showing the notched end of the outer tube.
FIG. 13 is an enlarged fragmentary section taken from the area
bracketed by 13 in FIG. 11 showing the die of FIG. 11 in
detail;
FIG. 14 is a detailed perspective view of the die depicted in FIG.
11;
FIG. 15 is a detailed sectional view of another embodiment of a
die;
FIG. 16a is a detailed perspective view of an outer tube used with
the die of FIG. 15;
FIG. 16b is a detailed cross sectional view of the outer tube of
FIG. 16a taken along line 16b--16b.
FIG. 17 is a detailed cross sectional view of another die useful in
the invention, and
FIG. 18 is a perspective schematic showing of yet another
embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides an apparatus for compressing a stent
onto a catheter. In a preferred embodiment the catheter includes an
expansive means, such as a balloon over which the stent is crimped.
The apparatus comprises a retaining means for preventing the stent
from sliding along the catheter and a crimping means for applying a
substantially uniform, circumferential radial inward force to at
least a portion of the stent. The crimping means moves
longitudinally with respect to the stent and catheter
As shown in FIG. 1, all embodiments of the apparatus for crimping a
stent include an optional tube 10 having a first end 14 and a
second end 18. The tube may serve as a retaining means to prevent
the stent from sliding along the catheter. Tube 10 is characterized
by a first diameter in the absence of tension and a second smaller
diameter when longitudinal tension is provided on the tube. While
the interior of the tube has a round cross-section, the exterior
need not be round. Optionally, tube 10 has a longitudinal axis
coincident with the longitudinal axis of the apparatus. Tube 10
receives a catheter 22 (shown with a balloon 24 thereon) and a
stent 26 over the catheter and balloons to be crimped to said
catheter, the stent having an initial diameter prior to being
crimped and a final smaller diameter after being crimped. The tube
also helps to prevent or minimize the elongation of the stent
during the crimping process and protects the stent.
Tube 10 may comprise any material that exhibits a reduced diameter
upon the application of tension thereto and that has a relatively
smooth interior surface to avoid marking, scoring or otherwise
damaging the stent. The tube may be made of any material that is
softer than the die used to crimp the stent, that won't stick to
the stent and that won't damage the stent, including polymers. One
such material is polyester. However, materials such as teflon,
polyethylene, polyurethane and nylon may also be used.
Additionally, the tube, having an interior surface and an exterior
surface, may be made of a lubricious material or have a lubricious
coating thereon. One surface of the tube may be more lubricious
than the other. Preferably, the tube will be transparent or
translucent so as to facilitate the viewing of the stent position
therein. The tube must be round on the inside, but need be round on
the outside.
The tube may comprise a polymer braid as illustrated at 32 and in
FIG. 2. Individual strands 33 of a given polymer are interwoven as
shown in FIG. 2 to form tubular braid 32. The polymer strands must
be thick enough to provide structural integrity to the tube but not
so thick as to prevent elongation of the tube and the associated
constriction upon elongation. Moreover, the weave must be dense
enough as to prevent parts of the stent, depending on the design of
the stent, from penetrating the weave and becoming enmeshed in it.
In a preferred embodiment, individual strands 33 made of polyester
having a circular cross section of diameter 5/1000 inch. Strands 32
are woven together in a clothing weave to form tubular braid 32
with the weave being about 20 to about 90 picks/inch, desirably
about 32 picks/inch. The braid tube described is manufactured by
SCIMED Life Systems, Inc., Maple Grove, Minn. and/or SantaFe
Textiles, Inc., Los Angeles, Calif., or may be manufactured by any
other coil braider.
One embodiment of the present invention, as illustrated in FIG. 3,
comprises a crimping means consisting of a die 36 having a first
end 40, a second end 44 and a bore 48 within. The longitudinal axis
of the bore is coincident with the longitudinal axis of the
cathater 22. The bore is sized to crimp a stent carried on catheter
22 within tube 10 to its mounted diameter which is smaller than the
initial diameter of the stent. Tube 10 as shown partially rests
within bore 48 of die 36. The stent, located underneath tube 10 and
not depicted in the FIG. 3, is crimped to the catheter by providing
tension to tube 10 thereby reducing its diameter and causing it to
grip the stent and by sliding die 36 along tube 10 and catheter 22,
over the stent and tube. As depicted in FIG. 3, the bore may
optionally be tapered at the second end 44, the diameter of the
bore at the second end of the die 44 having a diameter smaller than
the initial diameter of the stent i.e. the desired crimped
diameter. Alternatively, the bore may be tapered inward from both
ends. Thus, the diameter of the bore at the first end of the tube
and at the second end of the tube will be greater than the diameter
of the bore in the middle of the tube. Die 36 may be made of any
material that is harder or less deformable than the stent to be
crimped including metals such as stainless steel and polymers such
as polycarbonate, acrylonitrile-butadiene-styrene copolymer, Nylon,
acetal, and PEEK (polyetheretherketone).
Tube 10 may further comprise a lubricious coating on the exterior
surface to facilitate the sliding movement of die 36 over tube 10
or on the interior surface to facilitate insertion of catheter 22
and stent 26 therein. Suitable lubricious coatings include, but are
not limited to, silicone and hydrophillic coatings involving
hydrogel polymers or the like, such as polymer networks of a vinyl
polymer and an uncrosslinked hydrogel, for example. Polyethylene
oxide (PEO) is a preferred hydrogel. A preferred vinyl polymer is
neopentyl glycol diacrylate (NPG). Other compositions include
copolymers of poly(ethylene-maleic anhydride). Such compositions
are more fully disclosed in copending U.S. patent application
"Lubricity Gradient for Medical Devices", Ser. No. 08/868301, filed
Jun. 3, 1997, and in copending U.S. patent application Ser. No.
08/409797 filed Mar. 24, 1995, both of which are assigned to the
same assignee as is the present invention and which are
incorporated herein by reference as well.
The apparatus may further comprise a die sliding device to
facilitate sliding the die over the stent. The die sliding device
provides a track along which the die may be slidably moved. The die
sliding device may be made of metals such as stainless steel and
polymers such as polycarbonate, acrylonitrile-butadiene-styrene
copolymer and PEEK (polyether ether ketone).
In one embodiment, illustrated in FIG. 4, a die sliding device
generally designated at 100 consists of a base 104 with two
vertical oriented end members 108 and 112 emanating therefrom.
Vertical end 108 has aperture 114 formed therein, while vertical
end 112 has a male conical protrusion 115 therefrom with an
aperture 116 formed therein. The diameter of aperture 116 is large
enough to accommodate the largest diameter catheter 120 desired to
be used with the present invention. A die 122 has an elongated
groove 124 formed on its bottom and is slidably mounted by means of
groove 124 on a track 128. An inner tube 138 is attached either
adhesively or by pressing to male protrusion 115 at end member 112
and extends through aperture 114 at the other end member 108. In
use, catheter 120 is inserted through aperture 116 into inner tube
138. Stent 140 is placed over the expandable stent bearing portion
of the catheter 142. Inner tube 138 is placed under tension by
pulling on end 138a causing the inner tube to grip stent 140 and
hold it in place over the expandable stent bearing region of
catheter 142. Die 122 is then slidably moved along the track 128
and over expandable stent bearing region of the catheter 142 as
indicated by the arrow until stent 140 is crimped. Catheter 120 may
then be removed after slidably moving die 122 back over the stent
to its initial position as shown in the Figure. Of course stent 140
and expandable stent bearing region of catheter 142 must be
inserted far enough into inner tube 138 to allow the die to pass
over them.
In another embodiment, illustrated in FIG. 5, a Y or similar shaped
frame generally indicated at 150 having a handle 152 and uprights
154 and 158, has two rods 162 and 166 mounted between uprights 154
and 158. A tubular or conical protrusion 175 with an aperture 174
therethrough extends out from upright 154. Aperture 174 extends
through upright 154. A second aperture 176 extends through upright
158. A die 178, having three bores 182, 186 and 190 is slidably
mounted on the rods 162 and 166 by means of bored 182 and 186,
respectively. Rod 162 traverses bore 182 while rod 166 traverses
bore 186. An inner tube 192 die extending outwardly through
aperture 174 folded back over and fastened to protrusion 175 at one
end, extends through die 178 and bore 190 therein and out through
aperture 176 in upright 158. Inner tube 192 may be adhesively
bonded to the protrusion or pressed on. Alternatively, protrusion
175 may be threaded (not shown) and a threaded collar (not shown)
screwed on, with the folded back portion of inner tube 192 wedged
between the collar and protrusion 175. In use, catheter 194 is
inserted in inner tube 192 through aperture 174 in upright 154, and
at least partially into bore 190 in die 178. Stent 193 is carried
on the catheter over the stent bearing region of the catheter
indicated generally at 198. Tension is applied to inner tube 192 by
pulling on the end 192a emanating from aperture 176 thereby
gripping stent 193 and holding it in place over the stent bearing
region of the catheter at 198. Die 178 is slidably moved along rods
182 and 186 as indicated by the arrow such that stent bearing
region 198 of catheter 194 passes through bore 190 thereby crimping
the stent.
FIG. 6 is a side view of a die 200, similar to those depicted in
FIGS. 3-5, showing stent bearing region generally indicated at 204
of a catheter 208 as it traverses a bore 212. Stent 216 is
compressed and crimped as it traverses bore 212 by movement of die
200 is indicated by the arrow. Extending through bore 212 is inner
tubing 217.
In another embodiment, illustrated in FIG. 7, a catheter 350 having
a stent bearing region generally indicated at 354, with a balloon
358 mounted thereon, and a stent 362, the stent having a first end
363 and a second end 364, is provided with a first peel away tube
366. First peel away tube 366, characterized by a predetermined
inner diameter, 366a, is located adjacent to the second end 364 of
stent 362 and serves as a stent retention means to prevent stent
362 from sliding along catheter 350 during crimping. A tapered peel
away tube 370 having a first end 374 with a first diameter and a
second end 378 with a second diameter, the second diameter being
larger than the first diameter, surrounds a portion of catheter 350
at the first end 363 of the stent 362 when moved as indicated by
the arrow. Tapered peel away tube 370 serves as a crimping means.
The second diameter of tapered peel away tube 370 is larger than
the diameter of uncrimped stent 362 while the first diameter of
tapered peel away tube 370 is smaller than the diameter of the
uncrimped stent. Optionally, the stent may rest in a sleeve (not
shown) to prevent nicking or other damage to the stent. In use,
tapered peel away tube 370 is slidably passed over stent 362 when
moved as indicated by the arrow. As the tapered end of tapered peel
away tube 370 passes over stent 362, the stent is crimped.
Following crimping first peel away tube 366 and tapered peel away
tube 370 may then be peeled away from catheter 350. Optionally, a
two part sleeve which can be broken off may be used to crimp the
stent in place of the tapered peel away tube.
Suitable materials for the first peel away tube and the tapered
peel away tube include scored polyethylene, polypropylene and
teflon. Preferably tapered peel away tube will 370 be made of a
clear or translucent material. Tapered peel away tube 370 must be
made of a material less deformable than the stent so that as it
passes over the stent, the stent will be crimped rather than the
tube being deformed. The first peel away tube 366 may be formed of
any material rigid enough to prevent the stent from sliding.
In another embodiment, the present invention discloses a
stent-crimping apparatus comprising a deformable tube and a tension
applying means for applying tension to the deformable tube and a
method of crimping a stent using the same. The stent bearing region
of a catheter, along with a stent, is inserted into the deformable
tube. As the tension applying means stretches the deformable tube,
the diameter of the tube decreases, thereby crimping the stent onto
the catheter.
As depicted in FIG. 8, a catheter 420 bearing a balloon 422 is
inserted in a deformable tube 424. Stent 426 is separately inserted
into deformable tube 424 so that it rests over at least a portion
of balloon 422. Deformable tube 424 has grips 430 at each end.
While grips 430 may be an integral part of deformable tube 424,
they may also be adhesively or pressure bonded to deformable tube
424. Deformable tube 424 will preferable be formed of a braid, the
characteristics of which have been discussed herein above. Grips
430 may be made of any material which facilitates holding onto the
device., including plastics and metals. In operation, a stent 426
is aligned over balloon 422 and tension applied to both grips 430
so as to stretch deformable tube 424. As deformable tube 424
stretches, its diameter decreases, thereby applying an inward force
to stent 426 and crimping it to balloon 422 and catheter 420.
The apparatus, shown in FIG. 9 illustrates an embodiment of the
above invention. The apparatus comprises a deformable tube 450
fixed at a first end 454 to a first arm 456, and fixed at a second
end 458 to a second arm 460. The two arms are pivotally connected
at 464. The first and second arms have apertures 468 and 472
therethrough respectively. In use, a catheter 476 is inserted
through the aperture 468 or 472, traversing the deformable tube 450
and exiting via the aperture 468 or 472 such that the stent bearing
region of the catheter (not shown) resides in the deformable tube.
A stent (not shown) is then inserted in deformable tube 450 so that
it rests over the stent bearing region of the catheter. Optionally,
a deformable sleeve (not shown) may be contained within the
deformable tube as well. As arms 456 and 458 are squeezed together
at 480 and 484, the arms exert a longitudinal tension on the
deformable tube, stretching deformable tube 450 and decreasing the
diameter of deformable tube 450 thereby crimping the stent to the
stent bearing region of the catheter.
In another embodiment the present invention provides a method for
crimping a crimpable stent onto a catheter, the catheter possessing
a stent bearing region. The stent is characterized by a first
diameter prior to crimping and a second, smaller diameter following
crimping. The method comprises the steps of placing a stent
coaxially on the stent bearing region of the catheter, and placing
a stent retaining means such as a deformable tube over the stent,
as discussed above. The deformable tube has a longitudinal axis,
and a first diameter in the absence of tension and a second,
smaller diameter when the tube is under tension along the
longitudinal axis. Longitudinal tension is placed on the tube so as
to fix the stent in place on the stent bearing region of the
catheter and to substantially prevent relative motion between the
tube and the stent. A stent crimping means such as a die containing
a bore is provided, a portion of the bore with a diameter smaller
than the first diameter of the stent. Relative sliding movement is
then provided between the stent crimping means and the stent, with
the stent crimping means traversing the stent bearing region of the
catheter and thereby crimping the stent.
In another embodiment, illustrated by FIG. 10a, the present
invention provides a method for affixing a stent 500 onto a
catheter 504. A stent 500 is placed coaxially on stent bearing
region generally indicated at 508 of catheter 504 including a
balloon 509 and a stent retaining means such as a deformable,
optional peel-away tube 512 is placed coaxially over stent bearing
region 508 of catheter 504. While peel-away tube 512 is depicted as
being tapered, it need not be tapered. Although allowably
deformable, the stent retaining means should prevent sliding of
stent 500. A crimping means such as a tapered tube 524 having a
first opening 528 with a first diameter and a second opening 532
with a second diameter, the second diameter being smaller than the
first diameter, is positioned coaxially over catheter 504. Although
the interior of tapered tube 524 is tapered, the exterior may be
tapered as well. As the crimping means (tapered tube 524) passes
over stent 500 as indicated by the arrow, stent 500 is partially
crimped onto catheter 504, as illustrated in FIG. 10b. After
tapered tube 524 has completely passed over stent bearing region
508, as depicted in FIG. 10c, stent 500 is crimped to catheter. The
crimping means (tapered tube 524) and deformable tube 512 may then
be removed, optionally, by peeling them off. Suitable peel-away
tube materials include scored polyethylene, polypropylene and
teflon.
As in the first of the above-mentioned embodiments, the tubes may
be made of a clear or translucent material so as to facilitate
positioning of the stent and catheter within. Optionally, the tube
may be made of a polymer braid or a metal braid such as nitinol
and/or have a lubricious coating on the inner surface of the tube.
The tube must be round on the inside although the exterior need not
be round.
It is understood that in all of the embodiments of the present
invention, whether explicitly stated or not, an optional protective
tube surrounding the stent may be included to protect the stent
from damage.
In those embodiments of the present invention in which a die is
used, as in the first embodiment, the die may be made of metal or
of a polymer. It is most desirable for the bore within the die to
be tapered such that the tapered diameter is smaller than the
initial diameter of the stent to be crimped.
In yet another embodiment of the present invention, the apparatus
discussed above are prepared with an automated mechanism (not
shown) to apply tension to the tube or slidably move the
appropriate tubes or shafts. The automated mechanism may include a
motor (not shown).
In yet another embodiment of the present invention, the apparatus
comprises a tubular plunger in communication with one end of an
inner tube. The plunger is slidably mounted in an outer tube. The
inner tube, which receives the stent and catheter, traverses the
inner bore of a slotted die. The other end of the inner tube is
fixedly attached to an end portion. The outer tube serves as a
sheath to protect the inner tube and preferably is slotted at one
end. The slotted end of the outer tube is received by the slots in
the die. In order to crimp the stent, the die is slidably moved
over the stent residing in the inner tube. As the stent passes
through the inner bore, at least a portion of the inner bore having
a smaller diameter than that of the uncrimped stent, the stent is
crimped down onto the catheter or onto a dilatation balloon mounted
on the catheter.
This embodiment of the device is illustrated in FIG. 11. A tubular
plunger 700 having a first end 702 and a second end 704 and
characterized by an inner diameter exceeding the diameter of the
uncrimped stent is attached to and in communication with a
deformable inner tube 710. Inner tube 710 receives stent 706 and
catheter 707 through plunger 700, and is fixedly attached to the
second end of the tubular plunger 704 by pressing, or the use of
adhesives. Deformable inner tube 710 has a first end 712 and a
second end 714. The device further comprises an outer tube 720
having a first end 722, and a second end 724. As depicted in FIG.
12, outer tube 720 is notched at second end 724 so as to have a
plurality of (two) oppositely situated wall sections 726 at the
second end. The second end of the plunger 704 is slidably mounted
in the first end 722 of the outer tube 720 and deformable inner
tube 710 resides within outer tube 720. A die 730 (depicted in
FIGS. 11a, b, 13 and 14) is slidably mounted on outer tube 720. Die
730 has an outer housing 732 and an inner housing 734 with an inner
bore 736 therethrough, inner bore 736 having a circular
cross-section at every point along the length of the inner bore.
Inner bore 736 is characterized by a minimum diameter, with the
diameter of stent 706 prior to crimping exceeding the minimum
diameter of the bore. A portion of inner tube 710 traverses inner
bore 736. Die 730 further has one or more slots 738 therethrough
arranged so as to receive the plurality of oppositely situated wall
sections 726 in sliding engagement. Finally, the device has an end
portion shown generally at 740 at the second end of outer tube 720.
Optionally, end portion 740 has a hole 742 therein from which
catheter 707 may emanate. Finally, reverting to FIG. 11, end
portion 740 may comprise a cap 750 mounted on the second end of the
outer tube. Cap 750 comprises a male part 752 extending inward to
which second end 714 of inner tube 710 is fixedly attached, either
by bonding, pressing or some other suitable method so that the
inner tube may be placed under pressure by pulling on the plunger.
Cap 750, prevents die 730 from sliding off of outer tube 720. Cap
750, like the outer tube, may be made of rigid materials including
polymers and metals. End cap 750 may be a separate piece or may be
molded as an integral part of outer tube 720. End cap 750
optionally has a hole within allowing for the insertion or removal
of the catheter from the inner tube.
Optionally, the device may further comprise a mandril 751 as shown
in FIG. 11 b. In one embodiment, the mandril may emanate from end
cap 750 and traversing inner tube 710 and plunger 700. Mandril 751
may serve as a guide for inserting the catheter and stent.
The plunger 700 may be made of any rigid material. Preferably, it
will be made of a clear material such as a polycarbonate. However,
other polymers or metals including stainless steel may be used as
well. As depicted in FIG. 11, the second end 704 of plunger 700 is
tapered. While not a necessary feature of the invention, the taper
allows for ease of mounting inner tube 710 on plunger 700. The
first end of plunger 700 is chamfered to facilitate receipt of the
stent therein, although the chamfering is not necessary to the
device.
The deformable inner tube 710 may be made of any deformable
material softer than the stent. The tube must be susceptible to
deforming in such a way that at least a portion of the tube
exhibits a reduced diameter upon stretching of the tube. While the
interior of the tube must have a circular cross section, the
exterior of the tube, while preferably having a circular
cross-section, need not have a circular cross section. The tube may
be a sheath formed from Teflon, polyethylene, polypropylene or any
other material softer than the stent. The tube may also consist of
a braid of constant pic count, preferably ranging from about 30 to
about 90, most preferably about 40. While a flat ribbon braid which
is tubular on the inside may be used, preferably a round braid will
be used. Suitable materials for a braid include polyimide or
polyester and nylon as well as metals such as Nitinol. Suitable
braid tubes are manufactured by SCIMED Life Systems, Maple Grove,
Minn., SantaFe Textiles, Inc., Los Angeles, Calif., or any other
coil braider. It is preferable that the tube be formed of a clear
or translucent material for ease of positioning the stent.
Optionally, there can be a step down in the inner tube diameter
between the first opening and the second opening of the tube. The
step down serves as a stop for ease of positioning the stent. The
diameter of the unstretched tube at the first end may exceed the
diameter of the uncrimped stent. The tube may be coated with either
a lubricity enhancing coating or a coating to enhance holding
forces on the outside or inside. To facilitate positioning the
stent relative to the catheter, the tube may be marked with
position markers and may further be made of a magnifying material
to facilitate visualizing the stent and catheter.
As in the previous embodiments, the deformable inner tube 710
serves not only to protect the stent from damage such as nicking,
but also serves to hold the stent in place during crimping and
prevent elongation of the stent.
The deformable inner tube 710 may be attached to plunger 700 by any
known means including adhesive bonding and press fitting (i.e.
frictionally bonding).
The outer tube 720, like the plunger, may be made of any rigid
material. Preferably, however, the outer will be made of a clear or
translucent material to enable the stent to be seen as it is
positioned. Optionally, outer tube 720 may further comprise a
magnifying window (not shown) so as to facilitate positioning stent
706. The magnifying window may be made of any magnifying materials.
The outer tube 720 may also be illuminated (not shown) to
facilitate viewing the stent. In operation, the outer tube 720
helps to contain the deformable inner tube 710 and prevent it from
protruding when the plunger is depressed. The plunger is depressed
while the stent is loaded. The outer tube further serves as a
protective packaging where the stent is prepackaged in the stent
crimping device. The walls of inner tube 710 may also be coated
with a lubricious coating to facilitate sliding the die over
it.
The die 730 may be made of any material harder than the stent,
including metals and polymers such as polycarbonate. Other suitable
materials include acetals, such as delrin, or lubricious materials
such as polyethylene and nylon. One embodiment of the die, shown in
FIG. 13 comprises an outer housing 732 and an inner housing 734 in
communication with one another, slots 738 between the inner housing
and the outer housing and an inner bore 736, traversing inner
housing 734. Although die 730 is depicted with baffles 739 thereon,
any ergonomic design to the outer housing may be used.
The diameter of the stent prior to crimping exceeds the minimum
diameter of the bore. Where the diameter of the bore is constant
along the length of the bore, the maximum and minimum diameters are
equivalent. Preferably, the bore will be tapered from one or both
sides of the die. In the former case, the bore tapers from a
maximum diameter at the first end of the die to the minimum
diameter at the second end of the die. In the latter case, as
depicted in FIG. 11, the diameter of the bore decreases along the
length of the bore until a region of minimum diameter is
encountered. Following the region of minimum diameter, the diameter
of the bore increases along the remaining length of the bore. The
region of minimum diameter may constitute a single point along the
length of the bore or may extend for a desired length. The taper
need not be symmetric. Thus, the taper of the bore on the first end
can extend over a greater or lesser length than the taper on the
second end. Finally, although die 730 is depicted with baffles 739
on the exterior, any ergonomic design for the exterior of the
baffle may be used.
In another embodiment of the die, as depicted in FIG. 15, the die
comprises an outer housing 745 and an inner housing defined by
inner housing members 746. Inner housing members 746 are attached
to the outer housing via posts 747. Preferably, posts 747 are made
of a springy material, including stainless steel and nitinol,
allowing the diameter of the substantially circular inner bore 748
to be varied. Slots 749 lie between outer housing 745 and the inner
housing members 746. In operation, such a die allows for the
crimping of a variety of stents with different diameters to
balloons of differing diameters. As the stent and balloon enter the
die, inner housing members 746 retracts until the spring force is
sufficient to begin crimping the stent. This will occur when the
compression is such that the spring force exceeds the maximum force
to which the stent can be subjected without deforming. The use of
the springy material ensures the application of a consistent crimp
retention force over a variety of stent and balloon diameters. Of
course, the outer tube must be slotted so as to cooperate with the
slots 749. One such tube is shown generally at 760 in FIG. 16a. The
tube has three side walls 762. A sectional view of the slotted end
is shown at 766 in FIG. 16b.
In another embodiment of the die, as depicted in FIG. 17, die
generally indicated at 770 comprises a tubular outer housing 771
and two spaced half-tubular inner housing elements 772. Coil
springs 773 line the space between tubular outer housing 771 and
half-tubular inner housing elements 772. Half-tubular inner housing
elements 772 define a bore 774 for receiving the stent and catheter
(not depicted) with a substantially circular cross-section.
Although springs 773 are not directed radially inward, the
invention also contemplates the use of springs oriented radially
inward. Tubular outer housing 771 as well as half-tubular inner
housing elements 772 may be made of the same materials as those
used for other embodiments of the die such as stainless steel and
polymers such as polycarbonate, acrylonitrile-butadiene-styrene
copolymer, Nylon, acetal, and PEEK (polyetheretherketone). As the
catheter and stent (preferably in an inner tube) with a diameter
exceeding the diameter of inner bore 774 are inserted into bore
774, springs 773 compress. When springs 773 are sufficiently
compressed that the force exerted by the springs exceeds the
maximum force to which the stent may be subjected without
deformation, the stent will compress. For a given choice of spring
with given spring constant, this design allows for a variable crimp
depending on the physical properties of the stent being crimped.
Stents made of materials less susceptible to deformation will not
be crimped to the same extent as stents more susceptible to
deformation. This is in marked contrast to those die embodiments
which do not use springs. Absent the springs, all stents passing
through the die will be crimped to a diameter equal to the minimum
diameter of the inner bore.
In operation, stent 706 is crimped to the balloon and catheter as
depicted in FIG. 13 by inserting stent 706 and catheter 707 through
the plunger and into inner tube 710, positioning stent 707 over
stent bearing region 709 and sliding die 730 along outer tube 726
such that die 730 passes over stent 706 and applies a uniform
radial inward force to the stent. Preferably, when the stent is
inserted, the inner tube should be placed under sufficient tension
that its diameter is approximately equally to that of the uncrimped
stent. The stent may then be positioned relative to the catheter by
tilting the device downward and depressing the plunger. In so
doing, the diameter of the inner tube increases and, acting under
gravity, the stent slides down in the inner tube until it reaches
the desired location at which time the plunger may be pulled
outward to apply tension to the inner tube thereby reducing the
diameter of the inner tube and causing the inner tube to grip the
stent and hold it in place as the die passes over the stent. If the
stent goes too far in the inner tube, the process may be repeated,
tilting the device in the opposite direction although such a step
is not necessary if a step down braid or tube is included. Of
course, the position of the catheter may also be adjusted by
sliding the catheter relative to the stent.
The device may further comprise a ratcheting mechanism (not
depicted) or a locking mechanism to control the amount of tension
applied to the inner tube and lock the plunger into the package
place when a desired tension has been placed on the inner tube.
Such a mechanism would facilitate operation of the device by
eliminating the need to pull on the plunger as the die is moved and
the stent is crimped.
In yet another embodiment, as depicted in FIG. 18, the stent
crimping device shown generally at 1100 comprises an array of
longitudinal wires 1104 formed of a metal such as stainless steel
connected at one end with circular wire 1106 and at the other with
circular wire 1108, the wires arranged in a frustoconical assembly
1109. Surrounding the wires is a die 1110 with a circular bore 1112
therethrough. The diameter of the circle defined by circular wire
1106 exceeds that of the uncrimped stent while the diameter of the
bore 1112 is the desired diameter of the crimped stent. As can be
seen from the figure, the diameter of the circle formed by circular
wire 1108 is less than the diameter of the circle formed by
circular wire 1106.
In operation, a stent (not shown) is placed on a stent bearing
region of a catheter (not shown) and inserted through circular wire
1106 and into the frustoconical assembly. Die 1110 is slidably
moved toward circular wire 1106 drawing longitudinal wires 1104
inward on the stent and thereby crimping the stent.
Although the device depicted in FIG. 18 is shown as being formed
from four longitudinal wires as many as twelve longitudinal wires
or more may be used in making the frustoconical device.
The die 1110 may be made of any material stronger than the stent
and longitudinal wires to ensure that the stent is crimped rather
than die being deformed. Stainless steel is one such material.
Common to all of the various embodiments disclosed above is the
application of a uniform force to a compressible tube which, in
turn, transmits the force to the stent and thereby crimps it
uniformly on the catheter. The uniform force is applied in the
various embodiments in one of two ways: first, by sliding the tube
and its contents through a bore, preferably tapered so that as the
tube traverses the bore, the bore exerts a uniform force on a
circular cross section of the tube and second by elongating the
tube resulting in a uniform reduction of the diameter along the
tube. The bore may be the bore in a metal or polymer die or,
alternatively, the bore in a tube or sheath, the tube or sheath
optionally being tapered on the outside or the inside.
The crimping devices of the present invention may be prepackaged
with a stent contained therein for single use, a stent and a
catheter with an expandable region, or a stent, balloon and
catheter. Alternatively, the crimping devices of the present
invention may be used in conjunction with a stent prepackaged in a
deformable tube which may be inserted into the crimping device
along with the stent.
While this invention may be embodied in many different forms, there
are described in detail herein specific preferred embodiments of
the invention. This description is an exemplification of the
principles of the invention and is not intended to limit the
invention to the particular embodiments illustrated.
The above examples and disclosures are intended to be illustrative
and not exhaustive. These examples and descriptions will suggest
many variations and alternatives to one of ordinary skill in this
art. All these alternatives and variations are intended to be
included within the scope of the attached claims. Those familiar
with the art may recognize other equivalents to the specific
embodiments described herein which equivalents are also intended to
be encompassed by the claims attached hereto.
* * * * *